FDA.reportPublic FDA data

Ethambutol Hydrochloride

Product NDC
68850-004
11-digit product format
688500004
Labeler code
68850
Product ID
68850-004_f8939d3c-f0f7-4fb3-baf6-6b150c426f50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethambutol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
STI Pharma
Application
NDA016320
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2006-12-15
Marketing end
0000-00-00
Substance
ETHAMBUTOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e86e15b7-896a-6fb4-16e3-cf6efd994b64Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68850-004-012019-11-13C16284748780-197449f38-bd83-f6ea-e053-dbdaa90aa703Ethambutol Hydrochloride TABLETS USP 100 mg and 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68850-004-01Ethambutol Hydrochloride12 in 1 CARTONTABLET, FILM COATED122
68850-004-01Ethambutol Hydrochloride12 in 1 BOXTABLET, FILM COATED122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68850-004-01EA - Each68850-004b4509925-67aa-4b91-9d01-87506a50fdb212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ethambutol HydrochlorideACTIVE INGREDIENTQE4VW5FO07ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2
EthambutolACTIVE MOIETY8G167061QZETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2
GelatinINACTIVE INGREDIENT2G86QN327LETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2
Hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2
SorbitolINACTIVE INGREDIENT506T60A25RETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2
SucroseINACTIVE INGREDIENTC151H8M554ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68850-004ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]2Legacy NDC, 2 package rows20120817_d123fbd1-57de-47c6-963f-54d69427290b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995599ethambutol HCl 100 MG Oral TabletPSNd123fbd1-57de-47c6-963f-54d69427290b2
995607ethambutol HCl 400 MG Oral TabletPSNd123fbd1-57de-47c6-963f-54d69427290b2
995599ethambutol hydrochloride 100 MG Oral TabletSCDd123fbd1-57de-47c6-963f-54d69427290b2
995607ethambutol hydrochloride 400 MG Oral TabletSCDd123fbd1-57de-47c6-963f-54d69427290b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68850-004-016885000040112 in 1 CARTONHistorical